NCT04810078 (CheckMate-67T) is a Phase 3 clinical trial of Nivolumab and rHuPH20 in Clear Cell Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT04810078?

NCT04810078 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT04810078?

Interventions in NCT04810078: Nivolumab and rHuPH20, Nivolumab.

What condition does NCT04810078 study?

NCT04810078 studies Clear Cell Renal Cell Carcinoma.

Is NCT04810078 still recruiting?

NCT04810078 is currently active, enrolled. Last updated 9 October 2025.

Last reviewed 2025-10-09 · How we verify

NCT04810078: CheckMate-67T

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

Active, enrolled Phase 3 Last updated 9 October 2025

What this trial tests

Phase 3 trial testing Nivolumab and rHuPH20 in Clear Cell Renal Cell Carcinoma in 681 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 May 2021

Primary endpoint
29 July 2025

10 May 2027

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	681
Start date	21 May 2021
Primary completion	29 July 2025
Estimated completion	10 May 2027
Sites	89 locations across France, Italy, Finland, New Zealand, Russia, Chile, Ireland, Poland

Drugs / interventions tested

Nivolumab and rHuPH20 — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Clear Cell Renal Cell Carcinoma — all drugs for Clear Cell Renal Cell Carcinoma →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Clear Cell Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Updates on Immunotherapy and Immune Landscape in Renal Clear Cell Carcinoma.
Kim MC, Jin Z, Kolb R, Borcherding N, et al · · 2021 · cited 59× · PMID 34831009 · DOI 10.3390/cancers13225856
Renal cancer: signaling pathways and advances in targeted therapies.
Jiang A, Li J, He Z, Liu Y, et al · · 2024 · cited 18× · PMID 39092291 · DOI 10.1002/mco2.676
Subcutaneous versus intravenous nivolumab for renal cell carcinoma.
Albiges L, Bourlon MT, Chacón M, Cutuli HJ, et al · · 2025 · cited 13× · PMID 39288844 · DOI 10.1016/j.annonc.2024.09.002
Determining Front-Line Therapeutic Strategy for Metastatic Clear Cell Renal Cell Carcinoma.
Zarrabi KK, Lanade O, Geynisman DM. · · 2022 · cited 6× · PMID 36230530 · DOI 10.3390/cancers14194607
Strategies to target PD-1/PD-L1 in the tumor microenvironment.
Kui Y, Tong F, Zhang R, Dong X, et al · · 2026 · PMID 41784760 · DOI 10.1007/s13402-026-01181-x
Poster Abstracts
Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study.
Lonardi S, Ługowska I, O'Donnell A, Jackson C, et al · · 2025 · PMID 41052885 · DOI 10.1136/jitc-2025-011918
Model-Informed Drug Development of Subcutaneous Nivolumab: Comparison of Pharmacokinetic Analysis Methodologies Using Clinical Trial Simulation.
Zhao Y, Vezina H, Hu Z, Kondic A, et al · · 2025 · PMID 40990036 · DOI 10.1002/psp4.70120

Verify or expand the search:

Other trials of Nivolumab and rHuPH20

Trials testing the same drug.

NCT06697197 — A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other recruiting trials for Clear Cell Renal Cell Carcinoma

Currently open trials in the same condition.

NCT06863311 — Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear C · Phase 2 · recruiting
NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica · Phase 1, PHASE2 · recruiting
NCT07187778 — Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal · Phase 2 · recruiting
NCT07389629 — Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC · Phase 2 · recruiting
NCT06805825 — A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Expres · Phase 1 · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04810078 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 9 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04810078.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing